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The LCT 101 low level laser accessory is a non-heating infrared lamp powered by the MBM 1010 console, as per 21 CFR 890.550. It emits energy in the infrared spectrum, with an auxiliary visible red guide light. It is indicated for adjunctive use in the temporary relief of the hand and wrist pain associated with carpal tunnel syndrome.

NMA 100 Laser Accessory primarily consists of a hand held laser cluster accessory powered by the NMA 1052 Console. The hand held laser cluster contains the laser diodes and assembly, circuit board, electronics and labels. The hand piece is controlled from the console. The console automatically times the 33-second cycles of treatment.

The NMA 100 Laser Accessory is an 830 nm infrared laser indicated for adjunctive use in the temporary management of hand and wrist pain associated with carpal tunnel syndrome. The NMA 100 Laser utilizes three semiconductor laser diodes each emitting approximately 30 milliwatts (maximum 35 mW) continuous wave light at 830 nm. It utilizes 830 nm gallium-aluminum-arsenide laser diodes. The console automatically turns itself off after three joules of energy has been delivered.

The LCT 101 low level laser accessory is a non-heating infrared lamp powered by the MBM 1010 console, as per 21 CFR 890.550. It emits energy in the infrared spectrum, with an auxiliary visible red guide light.

The provided text describes a medical device, the NMA 1052 Console with NMA 100 Laser Accessory (also referred to as MBM 1010 Console System and LCT 101 Laser in later sections), and its 510(k) submission to the FDA. However, the text does not contain information about acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The document is primarily a summary of the device's specifications, its classification, predicate device, and the FDA's 510(k) clearance letter. It focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The response below will indicate where information is Not Found (NF).

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance: NF
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: NF
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: NF
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: NF (This device is a laser accessory for pain management, not an AI imaging analysis tool, so an MRMC study is not applicable in the traditional sense.)
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: NF (This device is a physical therapy device; "standalone performance" in the context of an algorithm is not applicable.)
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): NF
7. The sample size for the training set: NF
8. How the ground truth for the training set was established: NF

Additional Device Information from the Text:

• Device Name: NMA 1052 Console with NMA 100 Laser Accessory (also MBM 1010 Console System and LCT 101 Laser)
• Classification: Class II, Lamp, non-heating, for adjunctive use in pain therapy (21 CFR 890.5500)
• Predicate Device: MedX LCS Laser Series - K021985
• Intended Use: Adjunctive use in the temporary management of hand and wrist pain associated with carpal tunnel syndrome.
• Technical Specifications:
  • Hand-held laser cluster accessory powered by the NMA 1052 Console.
  • Emits 830 nm infrared laser light.
  • Utilizes three semiconductor laser diodes, each emitting approximately 30 milliwatts (max 35 mW) continuous wave.
  • Uses 830 nm gallium-aluminum-arsenide laser diodes.
  • Console automatically times 33-second treatment cycles.
  • Console automatically turns off after three joules of energy have been delivered.
• Regulatory Compliance:
  • Meets requirements of UL2606 standards in United Sates.
  • Health Canada - Medical Therapeutic Device approved.
  • UL Entela field evaluated and labeled (file FE-32134-1).
  • Underwriters Laboratories of Canada field evaluated (file FE:32505-2).

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The TriLumina Therapeutic Laser System is a non-heating infrared lamp and is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.

The TriLumina Therapeutic Laser is an innovative, safe, easy to use, hand-held, battery operated, non-invasive, athermal low energy infrared laser device. The TriLumina Therapeutic Laser contains three gallium-aluminum-arsenide continuous wave diodes operating in the near infrared at a wavelength of 830 nanometers and a visible red light emitting diode is used as a quide beam. The device has a power output of 30 milliwatts for each GaAlAs diode with a noncollimating beam of dimensions of approximately 1 by 3 millimeters at the lens. The Laser has an "On / Off" switch to control the power to the device and two pressure switches that when pressed energize the laser diodes. A timer automatically times the 30 second activation cycle and the delivery of 3 Joules of energy.

The provided text is a 510(k) premarket notification summary for the TriLumina Therapeutic Laser System. It focuses on demonstrating substantial equivalence to predicate devices and detailing the device's technical characteristics and intended use.

However, the document does not contain information about a study proving the device meets specific acceptance criteria related to its performance in temporarily relieving hand and wrist pain associated with Carpal Tunnel Syndrome. Instead, it relies on the substantial equivalence principle, comparing its technical specifications and intended use to already cleared devices.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance, nor can I answer questions regarding sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies. These types of studies would typically be conducted to prove clinical efficacy, which is often not required for 510(k) submissions that demonstrate substantial equivalence to previously cleared devices.

The document essentially states:

• Intended Use: Adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
• Mechanism: Non-heating infrared lamp (low energy therapeutic laser) using gallium-aluminum-arsenide continuous wave diodes at 830 nm.
• Basis for Clearance: Substantial equivalence to predicate devices (MicroLight 830 Laser System, Acculaser Pro Low Level Laser System, MedX LCS System) that are also low-level therapeutic lasers.

Without a clinical study described in the provided text, I cannot generate the detailed acceptance criteria and study information you requested.

Ask a specific question about this device